Ethics

Will my research require ethical approval?

Here are some general guidelines, but if you are in doubt then contact your local research ethics committee (REC) or the National Research Ethics Service, who have a useful pamphlet on this:  www.nres.nhs.uk/applications/is-your-project-research.

  • Case studies will not need approval, assuming they are part of your usual practice
  • Clinical audit and service evaluation will not usually need ethics approval if they are part of your normal practice. However, if you are setting up a new service or giving treatments specifically for the purposes of the research, then you should get advice
  • Surveys are usually OK
  • Clinical trials will need ethical clearance

Where do I apply for ethics approval?

  • If you are employed in the NHS or your research uses NHS patients then apply to your local NHS REC
  • If you are employed by a university, or affiliated to one, or your project has a strong university connection then approach their REC
  • Universities and the NHS host most healthcare research and account for most of the RECs in the UK. There are also a few independent RECs but they may be costly to use
  • Members can also apply to the British Acupuncture Council’s own REC. This is affiliated to the Central Office for Research Ethics Committees (COREC) (www.corec.org.uk). Further information and application forms are available here [LINK] *** not yet operational

The following Guidelines for ethical research are those supplied by the British Acupuncture Council for applicants for their research funding. The same principles should be considered whether or not you are applying for funding or formal ethical approval.

In general, the research should be conducted in a manner that protects the dignity, rights, safety and well-being of all actual or potential research participants. The information provided by the investigator must address the following ethics issues:

1.    Informed Consent

An individual should generally be accepted as a research subject only after she/he or, where necessary, the legally authorised guardian or next of kin has consented to participate in the research. The individual’s right of free choice must be respected. This requires that the decision to participate be made in the light of adequate and accurate information. (Certain exceptions to this principle, noted in the next section, may be made). It also should be made clear that the individual has the right to withdraw consent without penalty at any time. The consent must be voluntary and no form of coercion, direct or indirect, explicit or implicit should be employed. The individual should understand the risks, if any, involved and, where appropriate, be aware that the research may not be of personal benefit. A good template for writing Patient Information Leaflets and Patient Consent Forms can be found on the Department of Health website.

2.    Involvement of Individuals in Research in Which They Must Be Un-informed or Mis-informed

It is understood that some experiments, in order for the results to be meaningful or interpretable, require that the participants be unaware of the variables under investigation. Examples include the administration of sham electro-acupuncture or the covert observation of groups in society. The investigator must fully justify the use of such procedures and must ensure that the subjects are fully "debriefed" after the experiment. At the debriefing, subjects should be told the true purpose of the experiment, and the experimenter must take full responsibility for detecting and removing any stressful after-effects. This type of research will be carefully scrutinised, as well as that involving risks, keeping in mind the general question, "Is this study important enough to warrant the use of these procedures, especially if they may result in stress?”

3.    Statement of Risks and Benefits

A participant in an experiment is considered to be "at risk" if any aspect of the research exposes him/her to physical, psychological, social or other hazards. The investigator should specify these risks and make it clear that the subjects are also to be fully informed. The steps taken to minimise risks and the reasons why they cannot be avoided should be indicated. Where risks are involved, the possible benefits accruing from the research that may offset the dangers also should be noted. It is realised, especially in the case of basic research, that this may have to be speculative.

4.    Maintenance of Confidentiality

Every person has a right to privacy as regards most aspects of life, which only that person (or in certain cases a guardian or next of kin) can give permission to violate. When the possibility exists that others may have access to information gathered from research participants, it is required that this possibility, with the plans for protecting confidentiality, be explained to the participants as part of the procedure for obtaining informed consent. Similarly, statistical data must appear in publications in a manner that prevents individuals from being identified.

Further notes

  • Research ethics application forms are legendary for their length, detail and time consumption. It is advisable to make an informal approach first of all if you are in any doubt as to whether you need to get formal approval.
  • Having said that, you should be aware that funders may require REC approval and some journals may refuse to consider your work for publication without it.
  • REC members may know very little about acupuncture and acupuncture research. They may have a strong inclination towards quantitative, positivist research and may object strongly to trials that are not placebo controlled.
  • It is arguable the degree to which RECs should concern themselves with research design and methods rather than specifically ethical matters. Science-based RECs tend to take the line that poor or inappropriate methodology will waste the resources employed, including the participants, though they may not be the best qualified to judge appropriateness. Social science RECs tend to be less stringent in this respect.